PMID- 38360676 OWN - NLM STAT- MEDLINE DCOM- 20240219 LR - 20240223 IS - 1746-1596 (Electronic) IS - 1746-1596 (Linking) VI - 19 IP - 1 DP - 2024 Feb 15 TI - Clinical application of the HM-1000 image processing for HER2 fluorescence in situ hybridization signal quantification in breast cancer. PG - 32 LID - 10.1186/s13000-024-01455-8 [doi] LID - 32 AB - BACKGROUND: Accurate quantification of human epidermal growth factor receptor 2 (HER2) gene amplification is important for predicting treatment response and prognosis in patients with breast cancer. Fluorescence in situ hybridization (FISH) is the gold standard for the diagnosis of HER2 status, particularly in cases with equivocal status on immunohistochemistry (IHC) staining, but has some limitations of non-classical amplifications and such cases are diagnosed basing on additional IHC and FISH. This study investigated the clinical utility of a novel super-resolution fluorescence microscopy technique for the better FISH signal visualization and HER2 FISH classification. METHODS: Fourteen breast cancer tissue samples were retrospectively collected between September 2018 and February 2022, and FISH HER2 signal quantification was evaluated by determining the HER2/chromosome 17 centromere (CEP17) ratio and the number of HER2 signals per nucleus in super- versus conventional-resolution images. RESULTS: Super-resolution images maintained the same overall HER2 diagnosis from routine, but HER2 FISH amplification changed negative to monosomy in two cases. Two Letrozole non-response relapses coincided to monosomy samples. The median number of HER2 signals per nucleus was 7.5 in super-resolution images and 4.0 in conventional-resolution images in HER2-positive samples and 2.8 and 2.1 signals per nucleus, respectively, in HER2-negative samples. CONCLUSIONS: Super-resolution images improved signal visualization, including a significant difference in the number of countable HER2 and CEP17 signals in a single nucleus compared with conventional-resolution images. Increased accuracy of signal quantification by super-resolution microscopy may provide clinicians with more detailed information regarding HER2 FISH status that allows to better FISH classification such as HER2-low samples. CI - (c) 2024. The Author(s). FAU - Peg, Vicente AU - Peg V AD - Pathology Department, Vall d'Hebron University Hospital, Passeo Vall d'Hebron, 119-129, 08035, Barcelona, Spain. vicente.peg@vallhebron.cat. AD - Autonomous University of Barcelona, Barcelona, Spain. vicente.peg@vallhebron.cat. AD - Spanish Biomedical Research Centre in Cancer (CIBERONC), Madrid, Spain. vicente.peg@vallhebron.cat. FAU - Moline, Teresa AU - Moline T AD - Pathology Department, Vall d'Hebron University Hospital, Passeo Vall d'Hebron, 119-129, 08035, Barcelona, Spain. FAU - Roig, Miquel AU - Roig M AD - Pathology Department, Vall d'Hebron University Hospital, Passeo Vall d'Hebron, 119-129, 08035, Barcelona, Spain. FAU - Saruta, Yuko AU - Saruta Y AD - Sysmex R&D Center Europe GmbH, Hamburg, Germany. FAU - Cajal, Santiago Ramon Y AU - Cajal SRY AD - Pathology Department, Vall d'Hebron University Hospital, Passeo Vall d'Hebron, 119-129, 08035, Barcelona, Spain. AD - Autonomous University of Barcelona, Barcelona, Spain. AD - Spanish Biomedical Research Centre in Cancer (CIBERONC), Madrid, Spain. LA - eng PT - Journal Article DEP - 20240215 PL - England TA - Diagn Pathol JT - Diagnostic pathology JID - 101251558 RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Humans MH - Female MH - *Breast Neoplasms/diagnosis MH - In Situ Hybridization, Fluorescence/methods MH - Retrospective Studies MH - Neoplasm Recurrence, Local/genetics MH - Receptor, ErbB-2/genetics/metabolism MH - Monosomy MH - Gene Amplification PMC - PMC10868098 OTO - NOTNLM OT - Breast cancer OT - Fluorescence in situ hybridization OT - HER2 expression OT - Super-resolution microscopy COIS- V.P. has received fees as consultant, participated in advisory boards and received travel grants from Sysmex, Roche, Merck Sharp & Dohme, AstraZeneca, Bayer, Exact Sciences and Daiichi Sankyo. Y.S. is an employee of Sysmex R&D Center Europe GmbH. EDAT- 2024/02/16 00:42 MHDA- 2024/02/19 06:43 PMCR- 2024/02/15 CRDT- 2024/02/15 23:39 PHST- 2023/10/10 00:00 [received] PHST- 2024/01/28 00:00 [accepted] PHST- 2024/02/19 06:43 [medline] PHST- 2024/02/16 00:42 [pubmed] PHST- 2024/02/15 23:39 [entrez] PHST- 2024/02/15 00:00 [pmc-release] AID - 10.1186/s13000-024-01455-8 [pii] AID - 1455 [pii] AID - 10.1186/s13000-024-01455-8 [doi] PST - epublish SO - Diagn Pathol. 2024 Feb 15;19(1):32. doi: 10.1186/s13000-024-01455-8.